510(k) K011250 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jun 13, 2001 |
| Received | Apr 24, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011250
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.